Radius Health's (RDUS) CEO Robert Ward on Q4 2016 Results - Earnings Call Transcript

| About: Radius Health, (RDUS)
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Radius Health, Inc. (NASDAQ:RDUS) Q4 2016 Earnings Conference Call February 23, 2017 4:30 PM ET

Executives

Barbara Ryan - IR

Robert Ward - President and CEO

David Snow - Chief Commercial Officer

Nick Harvey - CFO

Dinesh Purandare - Head, Oncology

Lorie Fitzpatrick - CMO

Gary Hattersley - Chief Scientific Officer and SVP

Greg Williams - Chief Development Officer

Analysts

Jessica Fye - JPMorgan

Jenny Leeds - Bank of America Merrill Lynch

Kerry Tang - Goldman, Sachs & Co.

John Newman - Canaccord Genuity

Santhosh Palani - Cowen and Company

Mara Goldstein - Cantor Fitzgerald

Operator

Good afternoon, everyone. Welcome to Radius Health's Fourth Quarter and Full-Year 2016 Earnings Conference Call. Today’s call is being recorded.

At this time, I would like to turn the call over to Barbara Ryan. Please begin.

Barbara Ryan

Thank you. And welcome and thank you to those of you joining us on the line and the webcast this afternoon for a review of Radius Health’s fourth quarter and full-year 2016 financial and operating results. I am Barbara Ryan, Radius Health’s Investor Relations Officer. And with me this afternoon to discuss the results and update you on our progress are Robert Ward, President and Chief Executive Officer; David Snow, Chief Commercial Officer; Dr. Lorie Fitzpatrick, Chief Medical Officer; Dr. Greg Williams, Chief Development Officer; and Nick Harvey, Chief Financial Officer for Radius Health.

Before we begin, I’d like to remind you that any statements made during this call that are not historical facts are considered to be forward-looking within the meaning of the Private Securities Litigation Reform Act of 1965. Actual results may differ materially from those indicated by these statements as a result of various important risk factors, including those discussed in the risk factors section in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission and our other reports filed with the SEC. Any forward-looking statements represent our views as of today, February 23, 2017, only. A replay of this call will be available on the Company’s Web site, www.radiuspharm.com following the call. You can find the dial-in information for the replay in today’s press release as well as on the Company’s Web site.

It’s now my pleasure to turn the call over to Robert Ward, President and Chief Executive Officer of Radius Health.

Robert Ward

Thanks, Barbara. And thank you to everyone who’s joined us on our conference call and audio webcast this afternoon. 2016 was an important year in building the base of operations for Radius Health. As we drove substantial progress across the portfolio, while expanding our capabilities to ensure a sustained high performance.

In December, based on our assessment of the progress from a regulatory review process at the FDA, we green lighted all of the activities necessary to prepare for the commercial launch, including the hiring of the U.S sales force.

Today we’re only 34 days away from our March 2017 PDUFA in the U.S. In a few moments, David Snow, our Chief Commercial Officer will provide you with an update on our hiring and preparedness for launch. With a favorable on-time regulatory decision, we believe that the U.S represents an ideal biotech opportunity to directly commercialize low competitive intensity coupled with high unmet medical need.

In Europe, we continue to anticipate a CHMP opinion in 2017. We do not intend to develop commercial capabilities in the EU at this time. We’ve also guided that we intend to enter into a partnership by time of launch to ensure the commercialization of Abaloparatide in markets outside of the U.S.

We’re well funded to accomplish our goals and ended 2016 with $332.4 million in cash and equivalent. We are highly confident that Abaloparatide has the potential to become an important medicine to the treatment of osteoporosis.

And I would now like to introduce David Snow, who will review with you the substantial progress that’s been made on establishing our commercial capabilities.

David Snow

Thank you, Bob. I’m pleased to provide you with a commercial update on the evolution of Radius to a fully integrated biopharmaceutical company as we complete the build out of our sales, marketing, reimbursement, and distribution teams in preparations to support the commercialization of abaloparatide subcu in the U.S pending favorable regulatory review.

In the fourth quarter, we completed the hiring of our sales leadership team. And as Bob mentioned, in December we green lighted the hiring of our sales force in the U.S. We’ve been delighted by the outstanding response. The applicant pool has represented a highly qualified and experienced individuals with excellent track records of success. This response is a testament to both the organization and the data we’ve generated for abaloparatide subcu.

Successfully launching a specialty brand in the U.S require substantial planning, preparation and resources. I’m confident that we’ve done the necessary work and have the right talent in resources at Radius to succeed.

We expect to be fully staffed by the end of the first quarter, and will be prepared to launch in the U.S rapidly following approval. Our Market Access Organization is being lead by Amanda Mott, who bring substantial direct global biotechnology experience to our team.

Amanda has hired a highly skilled team of individuals with significant experience with large third-party payers and trade accounts that represent a substantial majority of the potential target patients. And they’re already active in discussions with health plans and PBMs. We fully believe that this will have a positive effect on commercial, and Medicare Part D plan decision making and acceptance.

Our marketing team is also comprised of seasoned professionals with substantial experience in specialty pharmaceutical marketing, communications, professional education and patient advocacy. We’ve already launched the disease state awareness campaign this year with healthcare providers and expanded our presence at key osteoporosis meetings.

The brand team is well down the path of finalizing campaigns and launch efforts across the healthcare providers, consumers, and payers. Finally and critically, we forged a comprehensive commercial operations team led by Ronan Gannon to support the wide array of launch requirements with a capable bench of individuals, with extensive experience in establishing hub in specialty pharmacy distribution networks, analytics and forecasting, market research, sales and marketing operations and sales training.

Having spent years in this function, I’m convinced this group can be a major source of competitive advantage. If approved, we intend to distribute abaloparatide subcu in the U.S through a network of distributors and specialty pharmacies.

Let me end my comment by discussing our sales team readiness. It started with a 20 plus capable sales leaders with prior osteoporosis managerial specialty launch, an injectable therapy experience brought on last year by our Vice President of sales, Ken Coyle.

In the first quarter, these sales leaders have already hired over 90% of our clinical sales specialist with a focus on identifying the most experienced team possible. The result is a sales team with substantial osteoporosis injectable that limits healthcare experience and nearly everyone has had prior launch experience. I think this is a great match to the depth of experience across our medical science liaison team and I'm confident this will translate into strong market performance.

I would now like to turn the call over to Dr. Lorie Fitzpatrick, our Chief Medical Officer to review the breadth of medical literature that’s been published on abaloparatide.

Lorie Fitzpatrick

Thank you, David. We’ve also been building our medical team at Radius, which is organized with key functions including medical affairs, pharmacovigilance, medical information, publication, lifecycle management, and health economics research. These teams include sufficient scientists and medical science liaisons with substantial experience in osteoporosis bone health, endocrinology, and women's health.

We are extremely gratified to have a growing number of important journals publish the results from our abaloparatide Phase 3 clinical trial. As many of you know, in August of last year, the Journal of the American Medical Association or JAMA published the results of our Phase 3 active trial showing that abaloparatide subcu treatment group demonstrated an 86% reduction in vertebral fracture and a 43% reduction in non-vertebral fractures.

In a pre-specified exploratory analysis, abaloparatide also reduced clinical fractures by 43% and reduced major osteoporotic fractures by 70%. All of these comparisons are to the placebo treatment group.

In September of last year, the Journal of Bone and Mineral research also published peer-reviewed data from the active trial which coincided with their annual scientific meeting. This study was a pre-specified analysis looking at baseline risk, which show that abaloparatide provided these benefits in all patients regardless of their age, their baseline bone mineral density or prior fracture.

And just this month the Mayo Clinic Proceedings published the results of the first six months of ACTIVExtend, which showed that when transitioning from the anabolic of abaloparatide to an antiresorptive agent alendronate, the fracture efficacy was maintained.

We're pleased to see the scientific literature continue to grow. For example, the recent review article from Dr. Steven Clarke in the European Menopausal Journal, MATURITAS, in which the complete clinical development program for abaloparatide was reviewed and the [indiscernible] discuss to review on the context of these data. We are pleased to see scientific and clinical interest continuing to grow around the program.

I would now like to turn the call over to Dr. Greg Williams, our Chief Development Officer, who will provide you an update on ACTIVExtend.

Greg Williams

Thank you, Lorie. In June of 2015, we reported on the results of the first six months of ACTIVExtend. And as Lorie mentioned, those results were just reported in the Mayo Clinic proceedings on February 1.

As a reminder, the Active trial design was an 18-month three arm trial where postmenopausal women at risk of an osteoporotic fracture were randomized to abaloparatide subcu, placebo or open-label Forteo. On completion of Active, the patients who are treated for the full 18 months with the abaloparatide subcu, who were with placebo were transitioned into the ACTIVExtend portion of the program.

In the ACTIVExtend study the enrolled patients were treated for 24 months with the bisphosphonate, Alendronate. As I mentioned earlier, we’ve reported on the first six month period of ACTIVExtend. Now this 24 months study has completed and we expect to report topline results in the second quarter of this year. We believe these results will be important in understanding the durability of the response to abaloparatide subcu treatment.

I would now like to turn the call back over to Bob.

Robert Ward

Thank you, Greg. In addition to working with regulatory agencies as they review our submission for abaloparatide, and building our medical and commercial teams, we’ve continued to advance across our pipeline. Last September at ASBMR, we presented the positive results from a human replicative clinical evaluation that optimized abaloparatide transdermal patch.

These results established an important demonstration of how we’ve changed the PK profile in our program to develop a bioequivalent transdermal patch. Currently we’re focused on completing the manufacturing scale up and other required activities needed to initiate a pivotal bioequivalent study.

We believe that the transdermal patch program has the potential to allow physicians to treat osteoporosis, but rarely is injectable drug. To have an opportunity to expand their practices to include the use of anabolic therapy. Also last year at the San Antonio Breast Cancer Symposium, we reported on the encouraging results of our ongoing Phase 1 studies of RAD1901 in advanced breast cancer.

We were pleased with the clear demonstration of activity in the 400 milligram treatment groups. In the first half of this year, we plan to engage with regulatory agencies to gain alignment on defining the next steps of the program, which would include a Phase 2 trial. Also in the first half of this year, we plan to report results from our now completed Phase 2b study in vasomotor symptoms.

Also in December of 2016, we submitted an investigational new drug application or IND for RAD140, a selective androgen receptor modulator discovered in-house at Radius. We expect to initiate a first-in-human Phase 1 study in women with hormone receptor positive breast cancer this year.

The progress with RAD1901 and the recent discoveries around RAD140 provide us with two very promising opportunities to expand our research and development efforts in breast cancer.

Now, I would like to turn the call over to you, Nick, our Chief Financial Officer.

Nick Harvey

Thank you, Bob. For the three months ended December 31, 2016, we reported a net loss of $52.7 million or $1.22 per share as compared to a net loss of $33.2 million or $0.77 per share for the three months ended December 31, 2015.

For the 12 months ended December 31, 2016, we reported a net loss of $182.8 million or $4.24 per share as compared to a net loss of $101.5 million or $2.56 per share for the 12 months ended December 31, 2015. The increase in net loss from the 2015 period to the 2016 period included an increase in non-cash stock-based compensation expense and was primarily attributable to the growth of the organization to continue our pipeline development and to prepare for potential sales of abaloparatide subcu.

We have experienced substantial growth in our headcount, which currently stands at 352 as of February 22, 2017. As Radius continues to advance towards the potential first commercial sales of abaloparatide subcue, we expect to continue to expand our headcount and make further investments in launch preparations.

Our cash, cash equivalents and marketable securities balance as of December 31, 2016 was $332.4 million. We believe that our cash, cash equivalents and marketable securities balance prior to the consideration of revenue from the potential future sales of any of our investigational products or proceeds from business development activities is sufficient to fund our development plans, U.S commercial scale up, and other operational activities into 2018.

I will turn the call back over to Bob.

Robert Ward

Thank you, Nick. 2017 will represent a major inflection point for Radius. We're just 34 days from our PDUFA in the U.S on March 30 for abaloparatide subcu and pending favorable regulatory review we will become a commercial company. Our MAA is under active review in Europe and we expect to see the CHMP opinion in 2017, and enter into a partnership by time of launch.

In terms of abaloparatide transdermal patch, we are currently working on the completion of activities which required for initiation of a pivotal bioequivalent study. We believe that abaloparatide is the greatest value un-partnered late stage asset in the biopharma industry.

We tried to complete the ongoing 400 milligram Phase 1 [technical difficulty] that studies in metastatic breast cancer during this year. And in the first half this year, we plan to engage with regulatory agencies to gain alignment on the finding next steps for the program, which would include design and implementation of a Phase 2 study.

We submitted an IND for RAD140 in December and are now prepared to initiate first-in-human studies in 2017. These two programs established a significant presence for Radius Health and a search for new treatment options for patients with breast cancer.

We will also be making presentations and hosting one-on-one meetings at three upcoming Investor Conferences over the next few months. The Cowen conference here in Boston and the Deutsche Bank conference also here at Boston and the Bank of America Merrill Lynch conference in Las Vegas.

I'd now like to ask Dr. Lorie Fitzpatrick, to highlight the upcoming scientific meeting in March.

Lorie Fitzpatrick

Yes. Thank you, Bob. We are delighted that we will have three plenary presentations and one poster with an associated oral talk on abaloparatide at this year's World Congress of Osteoporosis meeting on March 24 and 25, in Florence, Italy.

The first plenary session will evaluate the effect of abaloparatide on a high risk group of patients. And immediately following that lecture, there will be a second plenary talk on the positive effects of abaloparatide regardless of baseline risk factors.

The second day we will present the number needed to treat with abaloparatide for benefit compared to teriparatide. We are very excited about the science we will be sharing at this meeting. Back to you Bob.

Robert Ward

Thank you, Lorie. With an exciting year ahead of us, I'd now like to open up the call for your questions.

Question-and-Answer Session

Operator

Thank you. We will now be conducting a question-and-answer session. [Operator Instructions] Thank you. Our first question comes from line the of Jessica Fye with JPMorgan. Please proceed with your question.

Jessica Fye

Hey, guys. Thanks for taking my questions. First one is on the launch of abaloparatide. Can you talk about the timeframe within which we should expect commercial coverage that kind of come into place and then when we should expect Medicare coverage? And I guess in that interim period of coverage is scaling up, what actions can you take to help support the launch? And then I have a second one on patch. It sound like you’re being progressed on CMC scale-up. Can you talk about when you expect to have more clarity and what might be an appropriate time to talk to the FDA about the bioequivalent patch to approval for that product? And I guess, will you disclose to us when you’ve made batches of patches at commercial scale? Thank you.

Robert Ward

Thank you, Jess. I appreciate the question. I will take them in reverse order and then ask David to address more directly to the questions around reimbursement timeline. When you think about the patch, bridging studies such as bioequivalent, bridge us to an already approved drug. So when you think of the ongoing review for abaloparatide subcu, PDUFA is near at hand, but today it is not an approved agent by any regulatory agency. So really talking about line extensions would occur following approval. And of course we will come back with a timeline on the program itself as we move forward, so that we have transparency of where a patch sits in the development pipeline. Now, David I think, Jess is also interested in hearing more about pending positive regulatory approval as abaloparatide moves into the marketplace what will be the expected timeline for adoption on both commercial formularies as well as on the Medicare part D plans. Would you mind sharing with her our thinking around those items?

David Snow

Sure. Thanks, Bob. Jessica thanks for the question. I would expect to hear that question early in the Q&A. Certainly when you look at specialty therapies like this, reimbursement is crucial for our success. We have a very good team in place looking at the core set of plans and PBMs that would be critical for our success. We look at it from both the commercial side and the part D side. You might expect that in launches given the typical cycle apart the approvals, it should take us longer to get those in place given the long timelines, lead timelines there. So we fully expect that commercial plans will come online a bit more quickly, but again the early feedback that we've got we're feeling good about where we are, so we expect that in 2017 we should be doing well in terms of getting our foot in the door in terms of access and then certainly into 2018 timeline we would be feeling like we’ve been in a good place there. And also I want to emphasize the fact that when you look at the injectable agents within the class, we are talking about specialty positioning and often their prior offs here. So again it's as far as the plans themselves looking at it, I don't think they see these as high risk areas for them in terms of adopting, putting these on the plans and recognizing the fact that there's quite a bit of unmet need in the marketplace. So we’re pleased where we are and expect to see 2017 improvement in terms of access and as a good year to get it started.

Jessica Fye

Thank you.

David Snow

Shall I step into that second question real quick on some of the other support, as you might expect as well, support around the launch. We think that it's critical to have our salesforce trained in the right way. It is a specialty audience we're talking about here as we’ve taken a lot of care to make sure we get the right people and the right training that they’ve got. But we've also got certainly very strong since around the patient experience, how we can support patients to the hub and especially pharmacies that they probably will be using, you could imagine that there will be a lot of support in terms of education for physicians around it, looking at other potential opportunities around perhaps samples or other collateral materials that you certainly would expect any specialty launch to have. So we would expect to put an array of those programs out, but again this is a specialty therapy. It's a very tight audience in terms of who the prescribers are and I think we've got a good handle on what it would take to support those …

Robert Ward

Thank you, David.

Operator

Thank you. Our next question is from the line of Ying Huang with Bank of America Merrill Lynch. Please go ahead with your question.

Jenny Leeds

Hi. This is Jen on for Ying. So a couple of questions on abaloparatide. So, as the PDUFA date is approaching, I’m just curious how ready is your CMC facility and has FDA started the inspection, like inspection of the facility. And second one like we know that we’re also expecting EU approval like some time this year and have you got any updates on your European partnership? Thanks.

Robert Ward

Yes. So as we’ve guided previously, we have not changed our guidance. We would anticipate, we’re having a partnership in place by time of launch, we continue to engage in productive discussions and are looking forward to continuing that activity. With regards to regulatory process itself, we generally don't comment ongoing regulatory activities. As you know, all of the regulatory agencies do conduct inspections both of our sites and third-party sites and that generally happens early in the review cycle. Our PDUFA is on March 30 of 2017, so just 34 days from today.

Jenny Leeds

Okay. Thank you.

Operator

Thank you. Our next question is from the line of Salveen Richter with Goldman Sachs. Please go ahead with your question.

Kerry Tang

Hey, guys. Thanks for taking my questions. This is actually Kerry on the line for Salveen. First of all on RAD1901, when can we expect to see additional data, and is your plan -- for the program to initially develop that has monotherapy in last line of hormone positive advanced breast cancer, and how about combo studies? What is the progress there? And then, secondly just going back to the plans for the transdermal patch program, are you ready to start the bioequivalent study immediately afterwards or is there any other work that needs to be done? Thank you.

Robert Ward

Thanks for your question. The thing about transdermal patch what we’ve guided is that last year at ASBMR, in the late-breaking session where we shared the data around the changes from the PK profile. But the next step was to undergo completion of all the manufacturing CMC related activities to have patches produced from a batch that would be suitable for conducting a pivotal study, and that we would come back with great information as we move down the process of completing those steps. So with patch, we will be back with more information as we move through the year. For 1901, last year at San Antonio breast cancer we had opportunity to share the ongoing Phase 1 data from both the 400 milligram expansion cohort, the now completed dose escalation cohort, and separately the cohort of patients that were enrolled in the European FES-PET study. We're very pleased with the activity we saw on the 400 milligram dosing group and we've guided that this year we will go to seek engagement with the agency around next steps in the program ideally design of a Phase 2 trial that will enable us to identify a patient population where we and the agency view the high unmet medical need sufficient to have the potential for being considered for accelerated approval. We always post on our trials on contrast.gov and when the first patient is enrolled, we usually do a press announcement and so we've communications around that next step in terms of the new clinicals would be as those trials come online. Of course as programs complete, we do continuously seek to update the scientific and clinical community through scientific meetings. Generally our policy is as the meeting themselves announce accepted abstracts then we also share with the public how we will be participating at those meetings. So as we go through the year to various oncology meetings, we do anticipate being able to provide additional information.

Kerry Tang

Okay. Thank you.

Operator

Our next question is from the line of John Newman with Canaccord Genuity. Please proceed with your questions.

John Newman

Hi, guys. Thanks for taking my questions. I wondered if you could talk maybe in general terms and all about the size of the U.S salesforce? And then in terms of the launch focus, will you be targeting mainly prescribers where their primary treatment is Forteo or will you be targeting an audience that’s a little bit broader, which may include physicians that are not using Forteo at this time? Thanks.

Robert Ward

Yes, thanks for your question, John. At this moment we’re so close to our PDUFA date that we just want to remind everyone that today abaloparatide has not yet been approved by any regulatory agencies and any claims around abaloparatide times are safety and efficacy, made a determination by the various regulatory agencies. So with that in mind, when we look at the osteoporosis market, we're aware of the high unmet medical need. Each year in the U.S alone 2 million individuals experience an osteoporotic fracture, 8.9 million globally. Today a very small number of those patients are diagnosed and treated with anabolic agents. So if you said, of those patients who are high risk of a subsequent fracture, the numbers that are not currently being diagnosed are being administered anabolic therapies far exceeds the number that are currently receiving therapy. We believe because of this high unmet medical need, it will be important to change how physicians think about managing osteoporosis. We're very pleased last year to see for the first time treatment guidelines that suggests that anabolic should be considered as first-line option for patients with the recent fracture. And in the scientific and clinical communities, often there is a discussion around treat to goal or the question of, is there a way to identify treatment practice parameters that allow physicians to think about how to help patients manage their disease in a way that they can make progress. Dr. Fitzpatrick, would you mind just sharing with us as you think about those trends in medical treatment, both the implications of the treatment guidelines and will treat to goal will be more commonplace in the market than it might be today.

Lorie Fitzpatrick

Thank you, Bob. It’s a very interesting topic as it does appear that guidelines are changing and shifting and there is quite a bit of new publications that have come out that support this. I think one of the important areas that came out recently were the American College of Clinical Endocrinologists put out their new guidelines for the first time they had an anabolic as a first-line treatment for patients who were at high risk for fracture. I think anabolic therapy has always been sort of been second or third line within the guidelines even though most of us think that many patients would surely benefit by having it as the first-line. So that’s one thing that's changed. The other thing that changed is there are several commentaries including the treat to goal saying how can you get to the goal fastest? And actually what’s the more cost effective way to do it, especially if you already have had a fracture and now we’re at really high risk for the second fracture. And in those cases, I think it's pretty clear and cost-effective that by giving an anabolic first and then extending treatment with an antiresorptive agent, you end up with really what’s very best for the patient in increasing their BMD and decreasing the fracture rapidly. And that’s kind of the key to this high risk population, who had a fracture. You really want to intervene rapidly and that’s one of the key notes that we’re going to be looking at I think in our studies as we go further looking at about teriparatide.

Robert Ward

So John, we do believe that there is a group of physicians today who are already routinely using anabolic therapies. And then a larger number of physicians who while they use injectable agents are not necessarily high prescribers of anabolic, and then an even larger number of physicians who treat osteoporosis that rarely use injectable agents. So we do think that physicians in each of these groups will be looking at the emerging clinical data about not just be about teriparatide program, but other programs in the marketplace to ask the question of how do they help their patients best address the unmet medical needs of osteoporosis.

John Newman

Okay, great. Thank you.

Operator

Thank you. Our next question comes from the line of Chris Shibutani with Cowen. Please proceed with your question.

Santhosh Palani

Hi. This is Santhosh on for Chris. Thank you for taking my question. I just wanted to get a little bit more clarity on when we should expect the CHMP opinion. So it's already been well over 12 months now since the EMA validated the application. You had mentioned that the CHMP opinion should come in 2017. I was just wondering since some of the aspect is more about the clock being stopping and you having the opportunity to enter the question, whether you could a little bit more that over timeframe until then we should be expecting the opinion? Thanks.

Robert Ward

Yes, you’re correct. We do expect that the regulatory decision in the U.S will come in advance of the European regulatory decision and we don't comment on ongoing regulatory activities. We are engaged with both agencies. And you are correct, we did guide that in 2017 we would be looking to receive a CHMP opinion.

Santhosh Palani

Thanks.

Operator

Thank you. The next question is from the line of Mara Goldstein with Cantor Fitzgerald. Please proceed with your question.

Mara Goldstein

Thanks very much. I appreciate it. I had a question on the distribution model with the specialty distribution network of pharmacies and so what I’m wondering as if you might share with us to the extent that you can, some other thoughts around fulfillment and delivery of drug and what -- and where you see the competitive advantage for you relative to what’s already out in the market?

Robert Ward

Yes. Thank you, Mara. That’s such an important consideration. When specialty drugs involve in autoinjector, it really becomes important that the patients be trained, have a patient support hotline to call if they have questions, have access to a nurse educator and quite often need support on reimbursement. So as we look to part in the marketplace and asked one of the existing services that have been provided around drugs that have been the most successful. Quite often, we've gotten feedback that [indiscernible] has just done a terrific job around Humira, that physicians feel that the way the program operates has been one that’s often referred to as a gold standard. So as we think about the importance of patients being able to appropriately learn to autoinject to avoid errors, to have the ability to reach out and have their questions answered, we wanted to make sure that our hub services are able to provide that same level of support.

Mara Goldstein

And if I could just ask, what are the key things obviously for individuals who will be able to have access to abaloparatide will be reimbursement around that. And so, will you have programs in place, essentially to break that gap, while the insurance aspect is being worked out.

Robert Ward

You’re right, Mara. Often with specialty [indiscernible], one of the questions that comes to mind is from the time of the first script until the patient is gone through the reimbursement process. How does one ensure that patients are able to move through? Well, sometimes can be a complex process in a reasonable period of time and be able to comfortably have an expectation that they would be able to fill their prescription. And that's why having the whole hub service put in place is so important. In the market today, there are anabolic agents whether offices that are routinely using these agents and they currently have in place ways that they have managed navigating both the training and reimbursement elements of using anabolic agents. Other offices that may be adopting anabolic agents for the first time require support to put that in place. So we're prepared to work not only with offices that already have means of addressing these issues, but also through our offerings, enable new prescribers to feel that they’ve the ability to gain support whether it's training in office or ensuring that patients have delivery with a hotline for service provision.

Mara Goldstein

Okay. Thank you.

Operator

Thank you. [Operator Instructions] Thank you. At this time, I will turn the floor back to Mr. Ward for further remarks.

Robert Ward

Great. Well, thank you everyone for joining us for our quarterly call and we look forward to seeing you again next quarter. Now today we changed to a call at the end of the day for the convenience of stockholders in different time zones. Our next call will also be held at the end of the day. So thank you very much for your participation.

Operator

Thank you. This conclude today’s teleconference. You may disconnect your lines at this time. Thank you for your participation.

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